The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0437-2013·Announced 2012-12-05

Zimmer Recalls NexGen Knee Components Due to Manufacturing Cleaning Defects

Zimmer is recalling specific lots of NexGen knee components because they were processed outside validated cleaning parameters, potentially leaving residual particulate.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of allergic reaction due to foreign material, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is initiating a lot-specific recall of the NexGen Stemmed Nonaugmentable Tibial Component. The recall affects 123 units worldwide, including 33 units in the United States. The devices are identified by Catalog 00-5986-047-02 and lots 62049114 and 62045235.

The recall was initiated because the devices were processed through a manufacturing cleaning operation that was operating outside of validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. The NexGen system is a semiconstrained, nonlinked condylar knee prosthesis indicated for patients with severe knee pain and disability due to various conditions, including rheumatoid arthritis and osteoarthritis.

The identified risks include allergic reactions due to the foreign material or late-onset issues. The devices were distributed in the United States (including AZ, CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, and WA) and internationally to Thailand, Canada, Germany, France, the UK, Hungary, the Netherlands, the Russian Federation, and Sweden. Patients and healthcare providers should contact Zimmer for further instructions regarding the affected devices.

The recalled product

Product
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic…
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog 00-5986-047-02
  • lots 62049114 and 62045235.

Distribution

Distributed in 13 states:

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